Enterprise Quality Management Software (EQMS Software)

Welcome to Scalable Quality Control for Regulated Industries

Looking to unify your quality processes, reduce risk, and streamline compliance? Zebsoft’s Enterprise Quality Management Software (EQMS Software) connects every part of your QMS in one secure, scalable platform. Whether you’re working toward ISO 9001, managing medical device compliance under ISO 13485, or operating under FDA 21 CFR Part 11, Zebsoft gives you the control, visibility, and proof you need to lead with confidence.

Modules. Build your compliance domain.

Bring one or more standards together to build your compliance domain.

From Chaos to Control: Why Businesses Choose Zebsoft EQMS Software

Disconnected spreadsheets. Siloed teams. Missed audits. Inconsistent training records. If you’re still managing quality through patchwork systems, you’re vulnerable to compliance failure, product delays, and brand damage.

Zebsoft replaces this chaos with a connected, enterprise-grade QMS designed to:

  • Ensure compliance across multiple standards (ISO, FDA, GxP)
  • Create accountability with role-based visibility
  • Provide real-time reporting for audits and executive reviews
  • Reduce manual admin with automation and pre-built workflows

“We passed our ISO 9001 recertification audit with zero findings. Zebsoft made it effortless.”

Core EQMS Modules Built In

Zebsoft includes everything you need to run a compliant, auditable, and scalable QMS:

📊 Document Control

  • Version-controlled SOPs, policies, and forms
  • Approval workflows and automated review reminders
  • Read receipts and role-based access

🔹 Audit Management

  • Internal and external audit scheduling
  • Non-conformance capture and follow-up tasks
  • Integrated audit dashboards

🔑 CAPA Software

  • Log non-conformances from any module
  • Root cause analysis, 5 Whys, Ishikawa diagrams
  • Corrective and preventive action tracking

🔧 Risk Management

  • ISO 14971 & ISO 31000-aligned risk matrix
  • Risk-control linkage across processes
  • Live dashboards and mitigation tracking

🏢 Training & Competency

  • Assign training by role or regulation
  • Upload certificates, track completions
  • Competency matrix and renewal workflows

🔢 Change Control

  • Formal review and approval workflows
  • Full traceability of changes by user and time

📈 Quality Dashboards

  • Custom KPIs across modules
  • Real-time reporting for management reviews
  • Exportable reports for regulators or customers

Built for ISO, FDA, GxP and More

Zebsoft’s EQMS Software is designed to meet the real-world demands of regulated industries, where compliance isn’t optional — it’s business-critical.

Whether you’re audited by ISO certification bodies, FDA inspectors, or your own internal governance board, Zebsoft gives you the tools to:

✅ Align with ISO 9001, ISO 13485, ISO 14971, ISO 45001, IATF 16949
✅ Satisfy FDA 21 CFR Part 11 for electronic records and signatures
✅ Support GxP principles (Good Manufacturing, Laboratory, Distribution Practice)
✅ Prepare for regulatory inspections, notified body audits, and supplier qualification

We don’t just mention the standards — we build our platform to align with them:

  • Pre-configured workflows based on ISO and FDA expectations
  • Validation support (IQ/OQ/PQ) available for life sciences
  • Electronic signatures, audit trails, and traceability for every record
  • Role-based access and change control for secure, compliant use

Your EQMS shouldn’t just store documents. It should actively support your ability to pass audits, prove quality, and build trust — that’s what Zebsoft does.

Technical Compliance, Validation & Security

Zebsoft supports computer system validation (CSV) and aligns with regulatory expectations:

  • Part 11 compliant electronic signatures & audit trails
  • IQ/OQ/PQ documentation available
  • Data encryption, UK/EU cloud hosting, and robust permission control
  • Validation packages available for regulated deployments

Learn more about ISO 9001 quality standards

Who its for:

An EQMS (Enterprise Quality Management System) is a digital platform that centralises all quality processes such as audits, document control, CAPA, and training across a business.

Zebsoft supports ISO 9001, ISO 13485, ISO 45001, ISO 14971, IATF 16949, and FDA 21 CFR Part 11.

Yes. Zebsoft is built to support compliance with ISO, FDA, and GxP requirements. Validation documentation and Part 11-ready features are included.

Yes. Zebsoft is multi-site and multi-standard capable, with role-based permissions and site-level controls.

Yes. We provide full onboarding, optional validation packages, and access to certified consultants.

The combined elements of this configuration:

Legal & Compliance Register

Centralise all external requirements by domain or business area.

Risk Register

Score, own, and monitor enterprise risks by department or site.

Change Control

Tie changes to impacts, risks, and linked processes.

Policy Management

Publish, version, and assign policies with approval workflows.

Process-Embedded Controls

Build processes essential to daily operations.

Live Dashboards

Visualise GRC status in real time — across teams and locations.

What Our Users Say

“Zebsoft turned our compliance chaos into a competitive advantage.”
– Jane W., Quality Manager

“With Zebsoft we finally achieved our goals. No drama. No upset.”
– Simon R., Operations Lead